Alzheimer DiseaseMemento-PlusNCT04111211
Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
An observational study of Alzheimer Disease, run by University Hospital, Bordeaux at 26 sites in France.
Trial summary
Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- How many people
- 1,028 participants
- Where
- 26 sitesFrance
- Study dates
- 3 Dec 2019to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients from French Research Memory Centers and included in Memento cohort
Who may be able to join
- Participants aged over 18 year-old
- Being included in Memento cohort
- Affiliated person or beneficiary of a social security scheme.
- Participants capable of expressing non objection
- Non objection expressed by the tutor for participants under tutorship
- Non objection expressed by the participant assisted by their guardian for participants under guardianship
- Non objection expressed by the trusted person (in accordance with art. L1111-6 of Code de la Santé Publique) for participants without the capacity to express non-objection and who are not under legal protection measure
Who cannot join
- Expressing opposition to participate in Memento-Plus
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
CHU d'Amiens
Amiens
AP-HP - CHU Avicenne
Bobigny
CHU de Bordeaux - Pellegrin
Bordeaux
CHU de Clermont-Ferrand
Clermont-Ferrand
Hôpitaux Civils de Colmar
Colmar, 68000
CHU de Dijon
Dijon
CHU de Grenoble
Grenoble
CHU de Lille
Lille
AP-HM
Marseille
CHU de Montpellier
Montpellier
CHU de Nancy
Nancy
CHU de Nantes
Nantes
CHRU de Nice - Institut Claude Pompidou
Nice
CHU de Nice - Hôpital de Cimiez
Nice
AP-HP - Hôpital BROCA
Paris
Ap-Hp La Pitié-Salpêtrière
Paris
APHP Groupe Hospitalier Saint Louis Lariboisière Fernand Widal
Paris
CHU de Bordeaux
Pessac
CHU de Poitiers
Poitiers
CHU de Rouen
Rouen
CHU de Saint-Etienne
Saint-Etienne
CHU de Strasbourg
Strasbourg
CHU de Toulouse - Hôpital Purpan
Toulouse
CHU de Toulouse
Toulouse
CHU de Tours
Tours
Hospice Civil de Lyon
Villeurbanne
About this study
Official title: Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive.
Many features of dementia render it especially challenging. Indeed development of disease occurs insidiously over the course of years or decade. In addition, the causes of dementia and determinants of its severity are likely multi-factorial.
Read more
To overcome these challenges and better understand the causes and course of AD and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers).
This project proposes an extension of the follow-up of Memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, related disorders, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Individuals at high risk of developing Alzheimer's dementia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease)
Measured: Each 12 months from baseline for 5 years
Secondary outcomes (7)
Mortality
Measured: Each 12 months from baseline for 5 years
Loss of autonomy based on functional activity assessment
Measured: Each 12 months from baseline for 5 years
Rate of cognitive decline based on change in cognitive performances
Measured: Each 12 months from baseline for 5 years
Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)
Measured: Each 12 months from baseline for 5 years
Quality of life: EQ-5D (EUROQOL)
EQ-5D (EUROQOL) questionnaire Subscales: VAS patient's self-rated health (0=worst, 100=best), mobility, self-care, usual activities, pain/discomfort and anxiety/depression (rated as no problems, slight problems, moderate problems, severe problems and extreme problems)
Measured: Each 12 months from baseline for 5 years
Incidence of prodromal AD (Pre-symptomatic dementia)
Measured: Each 12 months from baseline for 5 years
Incidence of institutionalization
Measured: Each 12 months from baseline for 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start3 Dec 2019
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève CHENE, Prof, Principal investigator, CIC-1401 EC - ISPED - CHU de BodeauxGeneviève CHENE, Prof, Study chair, CIC-1401 EC - ISPED - CHU de BodeauxCarole DUFOUIL, Director, Study director, CIC-1401 EC - ISPED - CHU de Bodeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111211
- Sponsor's protocol ID
- CHUBX 2019/16
- Acronym
- Memento-Plus
- Status last verified
- Feb 2025
- First submitted
- 27 Sep 2019
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memento-Plus : Long-term Follow-up of Cognitive and Functional Evolutions of Persons With Isolated Cognitive Complaints or Mild Cognitive Deficits
- ClinicalTrials.gov ID
- NCT04111211
- Acronym / sponsor ID
- Memento-Plus / CHUBX 2019/16
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer's disease, related disorders, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 1 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dementia is a clinical syndrome that is the result of distinct underlying pathologies including Alzheimer's disease (AD). Despite more than two decades of research on prevention and treatment of dementia and aging-related cognitive decline, highly effective preventive and therapeutic strategies remain elusive.
Many features of dementia render it especially challenging. Indeed development of disease occurs insidiously over the course of years or decade. In addition, the causes of dementia and determinants of its severity are likely multi-factorial.
To overcome these challenges and better understand the causes and course of AD and related disorders, long term follow-up studies of persons at high risk of dementia are required including multidimensional and harmonized assessment of risk factors, phenotypes (cognition, neuropsychiatric symptoms, physical health, self rated health) and endophenotypes (blood markers, genetic markers, neuroimaging markers).
This project proposes an extension of the follow-up of Memento participants over 5 to 10 years with of focus on cognitive outcomes and comorbidities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals at high risk of developing Alzheimer's dementia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients from French Research Memory Centers and included in Memento cohort
Key inclusion criteria (7 listed)
- Participants aged over 18 year-old
- Being included in Memento cohort
- Affiliated person or beneficiary of a social security scheme.
- Participants capable of expressing non objection
- Non objection expressed by the tutor for participants under tutorship
Key exclusion criteria (1 listed)
- Expressing opposition to participate in Memento-Plus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease)
Time frame: Each 12 months from baseline for 5 years
7 secondary outcomes
Mortality
Time frame: Each 12 months from baseline for 5 years
Loss of autonomy based on functional activity assessment
Time frame: Each 12 months from baseline for 5 years
Rate of cognitive decline based on change in cognitive performances
Time frame: Each 12 months from baseline for 5 years
Incidence of neurovascular and cardiovascular events (Stroke and Coronary events)
Time frame: Each 12 months from baseline for 5 years
Quality of life: EQ-5D (EUROQOL)
Time frame: Each 12 months from baseline for 5 years
Incidence of prodromal AD (Pre-symptomatic dementia)
Time frame: Each 12 months from baseline for 5 years
Incidence of institutionalization
Time frame: Each 12 months from baseline for 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève CHENE, Prof principal investigator
CIC-1401 EC - ISPED - CHU de Bodeaux
Geneviève CHENE, Prof study chair
CIC-1401 EC - ISPED - CHU de Bodeaux
Carole DUFOUIL, Director study director
CIC-1401 EC - ISPED - CHU de Bodeaux
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University Hospital, Bordeaux at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to clinical dementia stage according to standardized classifications (DSM-IV for dementia and NINCDS-ADRDA for Alzheimer's disease) (time frame: Each 12 months from baseline for 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.